PDS Biotech gets IND application clearance for colorectal cancer treatment
PDS Biotechnology (NASDAQ:PDSB) said on Thursday it received U.S. FDA clearance for its Investigational New Drug application ...
Business Wire1d
LGM Pharma Invests $6M in U.S. Drug Manufacturing Capabilities for Liquids, Suspensions, Semi-Solids, and Suppositories
The investment of over $6 million will expand LGM Pharma’s Rosenberg, Texas manufacturing facility as part of its Phase I ...
PDS Biotech Announces FDA Clearance of IND Application for Combination of Versamune® MUC1 and PDS01ADC to Treat Metastatic Colorectal Cancer
Phase 1/2 trial evaluating the proprietary combination to be run under CRADA with the National Cancer InstituteSecondVersamune®platform candidate ...
Ophthalmology Times2d
FDA accepts new drug application for low-dose atropine from Sydnexis
The FDA has set a PDUFA target action date of October 23, 2025, for the low-dose atropine formulation.
Access to Compounded GLP-1s Is Drying Up. Here’s What to Know About the Copycat Weight-Loss Drugs.
To be a person in the year 2025 is to encounter, in one way or another, the marketing onslaught for compounded ...
Becker's ASC1d
FDA advances new drug application for ketamine
Specialty pharmaceutical company PharmaTher Holdings’ drug application for Ketamine has received a June 4 approval goal date, advancing approval of the drug in the U.S. PharmaTher said it is ...
PharmExec13d
FDA Approves Investigational New Drug Application for Fapon Biopharma’s Novel Immunotherapy for Solid Tumors
FP008 is designed for patients with solid tumors that have not responded to existing immunotherapies targeting PD-1.
JD Supra9d
IP Hot Topic: Senate Bill Seeks to Create New Skinny Label Protections
A bipartisan Senate bill dubbed the “Skinny Label, Big Savings Act” was introduced in January. The bill would expand the scope of protection ...
Healio2d
FDA accepts new drug application for SYD-101 to treat pediatric myopia progression
The FDA accepted a new drug application for SYD-101 to slow the progression of pediatric myopia and assigned a Prescription ...
PharmaTher receives FDA priority review for ketamine new drug application
Ketamine stock PharmaTher Holdings (CSE:PHRM) has received an amendment acknowledgement letter from the U.S. Food and Drug ...
Aspire Biopharma Holdings, Inc., Provides Update on Recently Filed U.S. Patent Applications for Its Sublingual Drug Delivery Platform
HUMACAO, PUERTO RICO AND NEW YORK, NY / ACCESS Newswire / March 13, 2025 / Aspire Biopharma Holdings, Inc. (NASDAQ:ASBP) ("Aspire" or ...